A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors

Launched by SHANGHAI BAO PHARMACEUTICALS CO., LTD. · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called KJ015 for people with certain types of cancers that have a protein called HER2 on their tumor cells. These cancers include stomach, breast, colon, lung, bile duct, and head and neck cancers. The main goal is to see if KJ015 is safe and well-tolerated when given as an injection under the skin, and to get an early look at how well it might work against these tumors.

Adults 18 years and older who have tumors confirmed to have HER2 and whose cancer has grown despite previous treatments may be eligible to join. Participants need to be in reasonably good health aside from their cancer, with certain blood and organ function levels within a safe range, and expected to live at least three more months. If you join, you’ll receive the study drug and have regular visits to monitor your health and how your cancer responds. This study is still in the early phase and has not started recruiting yet, so it’s mainly focused on safety and finding the right dose rather than proving effectiveness at this stage.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged ≥ 18 years (at time of free and informed consent).
• • 2. Participants must have radiographically confirmed progressive disease (PD) during the last treatment prior to the first dose of enrollment.
• • 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) Dose Escalation Part: ECOG performance status 0 to 1;Backfill Part: ECOG performance status0 to 2.
• • 4. Participants must be have HER 2 positive or HER 2 expressing tumors determined by a certified local or central clinical laboratory or hospital
• 5. Organ function must meet the following criteria:
• • i.Hemoglobin (Hb) ≥ 9.0 g/dL ii.Absolute neutrophil count (ANC) ≥ 1.0 × 109/L iii.Platelet count (PLT) ≥ 80 × 109/L v.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN if no liver lesions (primary or metastatic); ALT and AST ≤ 5 × ULN if liver lesions are present vi.Creatinine clearance ≥ 30 mL/min vii.Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN viii. Serum albumin ≥ 25 g/L (2.5 g/dL).
• • 6. Expected survival ≥ 3 months.
• • 7. Participants must be capable of and willing to comply with the visit and procedure requirements outlined in the protocol.
• Exclusion Criteria:
• • 1. Concurrent participation in another clinical study.
• • 2. Received radiotherapy within 2 weeks prior to the first dose.
• • 3. Underwent major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose or plan to undergo major surgery during the study. Underwent interventional or ablation surgery aimed at treating the tumor within 2 weeks before the first dose.
• • 4. Prior allogeneic bone marrow transplant or prior solid organ transplant.
• • 5. Received systemic corticosteroids or other immunosuppressive treatments within 2 weeks prior to the first dose.
• • 6. Received an anthracycline cumulative dose of doxorubicin exceeding 500 mg/m2 or an equivalent dose of other anthracyclines prior to the first dose.
• • 7. History of leptomeningeal carcinomatosis or carcinomatous meningitis.
• • 8. Brain metastasis or spinal cord compression.
• • 9. Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.
• • 10. History of a serious allergic reaction to the investigational product, an inactive ingredient in the investigational product, or other monoclonal antibody.
• • 11. Women who are pregnant or breastfeeding as confirmed by pregnancy testing within 3 days prior to first dose.